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Document E2018G0830(02)
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2017
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2017
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2017
OJ C 305, 30.8.2018, p. 15–33
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
30.8.2018 |
EN |
Official Journal of the European Union |
C 305/15 |
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2017
(2018/C 305/12)
Subcommittee I on the free movement of goods
To be noted by the EEA Joint Committee
With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note the following lists concerning marketing authorisations for medicinal products for the period 1 July-31 December 2017, at their meeting on 23 March 2018:
|
Annex I |
List of new marketing authorisations |
|
Annex II |
List of renewed marketing authorisations |
|
Annex III |
List of extended marketing authorisations |
|
Annex IV |
List of withdrawn marketing authorisations |
|
Annex V |
List of suspended marketing authorisations |
ANNEX I
List of new marketing authorisations
The following marketing authorisations have been granted in the EEA EFTA States during the period 1 July-31 December 2017:
|
EU Number |
Product |
Country |
Date of authorisation |
|
EU/1/02/226 |
InductOs |
Iceland |
18.8.2017 |
|
EU/1/15/999 |
Zykadia (Switch to non-conditional) |
Liechtenstein |
31.8.2017 |
|
EU/1/16/1138 |
Venclyxto |
Liechtenstein |
31.12.2017 |
|
EU/1/16/1155 |
Kyntheum |
Iceland |
16.8.2017 |
|
EU/1/16/1155 |
Kyntheum |
Liechtenstein |
31.8.2017 |
|
EU/1/16/1155 |
Kyntheum |
Norway |
14.8.2017 |
|
EU/1/17/1179 |
Veltassa |
Iceland |
11.8.2017 |
|
EU/1/17/1179 |
Veltassa |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1179 |
Veltassa |
Norway |
9.8.2017 |
|
EU/1/17/1181 |
Spherox |
Iceland |
24.7.2017 |
|
EU/1/17/1181 |
Spherox |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1181 |
Spherox |
Norway |
13.9.2017 |
|
EU/1/17/1184 |
Riximyo |
Iceland |
11.7.2017 |
|
EU/1/17/1185 |
Rixathon |
Iceland |
11.7.2017 |
|
EU/1/17/1191 |
Dinutuximab beta Apeiron |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1194 |
Febuxostat Mylan |
Iceland |
11.7.2017 |
|
EU/1/17/1195 |
Erelzi |
Iceland |
14.7.2017 |
|
EU/1/17/1195 |
Erelzi |
Norway |
7.7.2017 |
|
EU/1/17/1196 |
Kevzara |
Iceland |
14.7.2017 |
|
EU/1/17/1196 |
Kevzara |
Norway |
5.7.2017 |
|
EU/1/17/1197 |
Oxervate |
Iceland |
24.7.2017 |
|
EU/1/17/1197 |
OXERVATE |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1197 |
OXERVATE |
Norway |
17.7.2017 |
|
EU/1/17/1199 |
Cuprior |
Iceland |
13.9.2017 |
|
EU/1/17/1199 |
Cuprior |
Liechtenstein |
31.10.2017 |
|
EU/1/17/1199 |
Cuprior |
Norway |
13.9.2017 |
|
EU/1/17/1200 |
Besponsa |
Iceland |
24.7.2017 |
|
EU/1/17/1200 |
Besponsa |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1200 |
Besponsa |
Norway |
13.7.2017 |
|
EU/1/17/1201 |
Skilarence |
Iceland |
14.7.2017 |
|
EU/1/17/1201 |
Skilarence |
Norway |
7.7.2017 |
|
EU/1/17/1202 |
Ucedane |
Iceland |
12.7.2017 |
|
EU/1/17/1202 |
Ucedane |
Norway |
5.7.2017 |
|
EU/1/17/1203 |
Insulin lispro Sanofi |
Iceland |
11.8.2017 |
|
EU/1/17/1203 |
Insulin Lispro Sanofi |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1203 |
Insulin lispro Sanofi |
Norway |
18.8.2017 |
|
EU/1/17/1205 |
Blitzima |
Iceland |
9.8.2017 |
|
EU/1/17/1205 |
Blitzima |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1205 |
Blitzima |
Norway |
1.8.2017 |
|
EU/1/17/1206 |
Tuxella |
Iceland |
9.8.2017 |
|
EU/1/17/1206 |
Tuxella |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1206 |
Tuxella |
Norway |
1.8.2017 |
|
EU/1/17/1207 |
Ritemvia |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1207 |
Ritemvia |
Iceland |
10.8.2017 |
|
EU/1/17/1207 |
Ritemvia |
Norway |
1.8.2017 |
|
EU/1/17/1208 |
Trimbow |
Iceland |
11.8.2017 |
|
EU/1/17/1208 |
Trimbow |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1208 |
Trimbow |
Norway |
9.8.2017 |
|
EU/1/17/1209 |
Reagila |
Iceland |
9.8.2017 |
|
EU/1/17/1209 |
Reagila |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1209 |
Reaglia |
Norway |
9.8.2017 |
|
EU/1/17/1210 |
Efavirenz/Emtricitabin/Tenofovirdisproksil Zentiva |
Norway |
8.8.2017 |
|
EU/1/17/1210 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva |
Iceland |
10.8.2017 |
|
EU/1/17/1210 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1211 |
Entecavir Accord |
Iceland |
5.10.2017 |
|
EU/1/17/1211 |
Entecavir Accord |
Liechtenstein |
31.10.2017 |
|
EU/1/17/1211 |
Entecavir Accord |
Norway |
20.10.2017 |
|
EU/1/17/1212 |
Mavenclad |
Iceland |
13.9.2017 |
|
EU/1/17/1212 |
MAVENCLAD |
Norway |
30.8.2017 |
|
EU/1/17/1212 |
MAVENCLAD |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1213 |
Maviret |
Iceland |
17.8.2017 |
|
EU/1/17/1213 |
Maviret |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1213 |
Maviret |
Norway |
7.8.2017 |
|
EU/1/17/1214 |
Bavencio |
Iceland |
4.10.2017 |
|
EU/1/17/1214 |
Bavencio |
Liechtenstein |
31.10.2017 |
|
EU/1/17/1214 |
Bavencio |
Norway |
25.9.2017 |
|
EU/1/17/1215 |
Fotivda |
Iceland |
13.9.2017 |
|
EU/1/17/1215 |
Fotivda |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1215 |
Fotivda |
Norway |
31.8.2017 |
|
EU/1/17/1216 |
Imraldi |
Iceland |
12.9.2017 |
|
EU/1/17/1216 |
Imraldi |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1216 |
Imraldi |
Norway |
11.9.2017 |
|
EU/1/17/1217 |
Nitisinone MendeliKABS |
Iceland |
19.9.2017 |
|
EU/1/17/1217 |
Nitisinone MendeliKABS |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1217 |
Nitisinone MendeliKABS |
Norway |
1.9.2017 |
|
EU/1/17/1218 |
Rydapt |
Iceland |
4.10.2017 |
|
EU/1/17/1218 |
Rydapt |
Liechtenstein |
31.10.2017 |
|
EU/1/17/1218 |
Rydapt |
Norway |
25.9.2017 |
|
EU/1/17/1220 |
Tecentriq |
Liechtenstein |
31.10.2017 |
|
EU/1/17/1220 |
Tecentriq |
Norway |
27.9.2017 |
|
EU/1/17/1220 |
Tecentriq |
Iceland |
5.10.2017 |
|
EU/1/17/1221 |
Kisqali |
Iceland |
12.9.2017 |
|
EU/1/17/1221 |
Kisqali |
Norway |
30.8.2017 |
|
EU/1/17/1221 |
Kisqali |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1222 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
Iceland |
8.11.2017 |
|
EU/1/17/1222 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
Liechtenstein |
31.10.2017 |
|
EU/1/17/1222 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
Norway |
27.9.2017 |
|
EU/1/17/1223 |
Vosevi |
Iceland |
16.8.2017 |
|
EU/1/17/1223 |
Vosevi |
Liechtenstein |
31.8.2017 |
|
EU/1/17/1223 |
Vosevi |
Norway |
8.8.2017 |
|
EU/1/17/1224 |
Xermelo |
Iceland |
4.10.2017 |
|
EU/1/17/1224 |
Xermelo |
Liechtenstein |
31.10.2017 |
|
EU/1/17/1224 |
Xermelo |
Norway |
3.10.2017 |
|
EU/1/17/1225 |
Symtuza |
Iceland |
5.10.2017 |
|
EU/1/17/1225 |
Symtuza |
Liechtenstein |
31.10.2017 |
|
EU/1/17/1225 |
Symtuza |
Norway |
11.10.2017 |
|
EU/1/17/1226 |
Lutathera |
Iceland |
10.10.2017 |
|
EU/1/17/1226 |
Lutathera |
Liechtenstein |
31.10.2017 |
|
EU/1/17/1226 |
Lutathera |
Norway |
3.10.2017 |
|
EU/1/17/1227 |
Entecavir Mylan |
Iceland |
4.10.2017 |
|
EU/1/17/1227 |
Entecavir Mylan |
Liechtenstein |
31.10.2017 |
|
EU/1/17/1227 |
Entecavir Mylan |
Norway |
27.9.2017 |
|
EU/1/17/1228 |
Tookad |
Iceland |
29.11.2017 |
|
EU/1/17/1228 |
TOOKAD |
Liechtenstein |
31.12.2017 |
|
EU/1/17/1228 |
TOOKAD |
Norway |
22.11.2017 |
|
EU/1/17/1229 |
Dupixent |
Iceland |
10.10.2017 |
|
EU/1/17/1229 |
Dupixent |
Liechtenstein |
31.10.2017 |
|
EU/1/17/1229 |
Dupixent |
Norway |
10.10.2017 |
|
EU/1/17/1230 |
Lacosamide Accord |
Iceland |
5.10.2017 |
|
EU/1/17/1230 |
Lacosamide Accord |
Liechtenstein |
31.10.2017 |
|
EU/1/17/1230 |
Lacosamide Accord |
Norway |
27.9.2017 |
|
EU/1/17/1232 |
Miglustat Gen.Orph |
Iceland |
30.11.2017 |
|
EU/1/17/1232 |
Miglustat Gen.Orph |
Liechtenstein |
31.12.2017 |
|
EU/1/17/1232 |
Miglustat Gen.Orph |
Norway |
27.11.2017 |
|
EU/1/17/1233 |
Zubsolv |
Iceland |
29.11.2017 |
|
EU/1/17/1233 |
Zubsolv |
Liechtenstein |
31.12.2017 |
|
EU/1/17/1233 |
Zubsolv |
Norway |
22.11.2017 |
|
EU/1/17/1234 |
Tremfya |
Iceland |
4.12.2017 |
|
EU/1/17/1235 |
Zejula |
Iceland |
4.12.2017 |
|
EU/1/17/1235 |
Zejula |
Liechtenstein |
31.12.2017 |
|
EU/1/17/1235 |
Zejula |
Norway |
27.11.2017 |
|
EU/1/17/1236 |
Trelegy Ellipta |
Iceland |
30.11.2017 |
|
EU/1/17/1236 |
Trelegy Ellipta |
Liechtenstein |
31.12.2017 |
|
EU/1/17/1236 |
Trelegy Ellipta |
Norway |
22.11.2017 |
|
EU/1/17/1237 |
Elebrato Ellipta |
Iceland |
30.11.2017 |
|
EU/1/17/1237 |
Elebrato Ellipta |
Liechtenstein |
31.12.2017 |
|
EU/1/17/1237 |
Elebrato Ellipta |
Norway |
27.11.2017 |
|
EU/1/17/1238 |
Nyxoid |
Iceland |
29.11.2017 |
|
EU/1/17/1238 |
Nyxoid |
Liechtenstein |
31.12.2017 |
|
EU/1/17/1238 |
Nyxoid |
Norway |
27.11.2017 |
|
EU/1/17/1239 |
VeraSeal |
Iceland |
30.11.2017 |
|
EU/1/17/1239 |
VeraSeal |
Liechtenstein |
31.12.2017 |
|
EU/1/17/1239 |
VeraSeal |
Norway |
1.12.2017 |
|
EU/1/17/1240 |
Cyltezo |
Iceland |
29.11.2017 |
|
EU/1/17/1240 |
Cyltezo |
Liechtenstein |
31.12.2017 |
|
EU/1/17/1240 |
Cyltezo |
Norway |
1.12.2017 |
|
EU/1/17/1241 |
Ontruzant |
Iceland |
30.11.2017 |
|
EU/1/17/1241 |
Ontruzant |
Liechtenstein |
31.12.2017 |
|
EU/1/17/1241 |
Ontruzant |
Norway |
27.11.2017 |
|
EU/1/17/1242 |
Ritonavir Mylan |
Iceland |
29.11.2017 |
|
EU/1/17/1242 |
Ritonavir Mylan |
Liechtenstein |
31.12.2017 |
|
EU/1/17/1242 |
Ritonavir Mylan |
Norway |
22.11.2017 |
|
EU/1/17/1243 |
Imatinib Teva B.V. |
Iceland |
30.11.2017 |
|
EU/1/17/1243 |
Imatinib Teva B.V. |
Liechtenstein |
31.12.2017 |
|
EU/1/17/1243 |
Imatinib Teva B.V. |
Norway |
22.11.2017 |
|
EU/1/17/1244 |
Tacforius |
Liechtenstein |
31.12.2017 |
|
EU/2/16/197 |
CLYNAV |
Iceland |
13.7.2017 |
|
EU/2/16/197 |
CLYNAV |
Liechtenstein |
31.8.2017 |
|
EU/2/16/197 |
CLYNAV |
Norway |
18.7.2017 |
|
EU/2/17/211 |
Prevomax |
Iceland |
13.7.2017 |
|
EU/2/17/211 |
Prevomax |
Norway |
6.7.2017 |
|
EU/2/17/212 |
Exzolt |
Iceland |
30.8.2017 |
|
EU/2/17/212 |
Exzolt |
Liechtenstein |
31.10.2017 |
|
EU/2/17/212 |
Exzolt |
Norway |
15.9.2017 |
|
EU/2/17/213 |
Innovax-ND-IBD |
Iceland |
11.9.2017 |
|
EU/2/17/213 |
Innovax-ND-IBD |
Norway |
18.9.2017 |
|
EU/2/17/214 |
VEPURED |
Iceland |
12.9.2017 |
|
EU/2/17/214 |
VEPURED |
Norway |
15.9.2017 |
|
EU/2/17/215 |
Suvaxyn PRRS MLV |
Iceland |
11.9.2017 |
|
EU/2/17/215 |
Suvaxyn PRRS MLV |
Liechtenstein |
31.10.2017 |
|
EU/2/17/215 |
Suvaxyn PRRS MLV |
Norway |
18.9.2017 |
|
EU/2/17/217 |
Nobivac LeuFel |
Iceland |
9.11.2017 |
|
EU/2/17/217 |
Nobivac LeuFel |
Liechtenstein |
31.12.2017 |
|
EU/2/17/217 |
Nobivac LeuFel |
Norway |
14.11.2017 |
|
EU/2/17/218 |
Bovilis Blue-8 |
Iceland |
1.12.2017 |
|
EU/2/17/218 |
Bovilis Blue-8 |
Liechtenstein |
31.12.2017 |
|
EU/2/17/218 |
Bovilis Blue-8 |
Norway |
19.12.2017 |
ANNEX II
List of renewed marketing authorisations
The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July-31 December 2017:
|
EU Number |
Product |
Country |
Date of authorisation |
|
EU/1/07/401 |
alli |
Iceland |
14.7.2017 |
|
EU/1/07/401 |
alli |
Liechtenstein |
31.8.2017 |
|
EU/1/07/401 |
alli |
Norway |
5.7.2017 |
|
EU/1/07/402 |
Increlex |
Iceland |
12.7.2017 |
|
EU/1/07/402 |
INCRELEX |
Norway |
5.7.2017 |
|
EU/1/07/403 |
Atriance |
Iceland |
11.7.2017 |
|
EU/1/07/416 |
Ecalta |
Iceland |
13.9.2017 |
|
EU/1/07/416 |
Ecalta |
Liechtenstein |
31.10.2017 |
|
EU/1/07/416 |
Ecalta |
Norway |
22.9.2017 |
|
EU/1/07/421 |
Glubrava |
Iceland |
30.11.2017 |
|
EU/1/07/421 |
Glubrava |
Liechtenstein |
31.12.2017 |
|
EU/1/07/421 |
Glubrava |
Norway |
22.11.2017 |
|
EU/1/07/424 |
Torisel |
Iceland |
24.7.2017 |
|
EU/1/07/424 |
Torisel |
Liechtenstein |
31.8.2017 |
|
EU/1/07/424 |
Torisel |
Norway |
1.8.2017 |
|
EU/1/08/446 |
Privigen |
Iceland |
4.12.2017 |
|
EU/1/08/446 |
Privigen |
Liechtenstein |
31.12.2017 |
|
EU/1/08/446 |
Privigen |
Norway |
5.12.2017 |
|
EU/1/08/453 |
Prepandrix |
Iceland |
4.12.2017 |
|
EU/1/08/453 |
Prepandrix |
Liechtenstein |
31.12.2017 |
|
EU/1/08/453 |
Prepandrix |
Norway |
5.12.2017 |
|
EU/1/12/784 |
Cuprymina |
Iceland |
11.8.2017 |
|
EU/1/12/784 |
Cuprymina |
Liechtenstein |
31.8.2017 |
|
EU/1/12/784 |
Cuprymina |
Norway |
9.8.2017 |
|
EU/1/12/787 |
Revestive |
Iceland |
13.7.2017 |
|
EU/1/12/787 |
Revestive |
Norway |
5.7.2017 |
|
EU/1/12/788 |
Seebri Breezhaler |
Iceland |
11.8.2017 |
|
EU/1/12/788 |
Seebri Breezhaler |
Liechtenstein |
31.8.2017 |
|
EU/1/12/788 |
Seebri Breezhaler |
Norway |
9.8.2017 |
|
EU/1/12/789 |
Enurev Breezhaler |
Iceland |
24.7.2017 |
|
EU/1/12/789 |
Enurev Breezhaler |
Liechtenstein |
31.8.2017 |
|
EU/1/12/789 |
Enurev Breezhaler |
Norway |
9.8.2017 |
|
EU/1/12/790 |
Tovanor Breezhaler |
Iceland |
14.8.2017 |
|
EU/1/12/790 |
Tovanor Breezhaler |
Liechtenstein |
31.8.2017 |
|
EU/1/12/790 |
Tovanor Breezhaler |
Norway |
9.8.2017 |
|
EU/1/12/794 |
Adcetris |
Iceland |
4.12.2017 |
|
EU/1/12/794 |
ADCETRIS |
Liechtenstein |
31.12.2017 |
|
EU/1/12/794 |
ADCETRIS |
Norway |
27.11.2017 |
|
EU/1/12/795 |
Forxiga |
Iceland |
13.9.2017 |
|
EU/1/12/795 |
Forxiga |
Liechtenstein |
31.10.2017 |
|
EU/1/12/795 |
Forxiga |
Norway |
27.9.2017 |
|
EU/1/12/796 |
Picato |
Iceland |
24.7.2017 |
|
EU/1/12/796 |
Picato |
Liechtenstein |
31.8.2017 |
|
EU/1/12/796 |
Picato |
Norway |
8.8.2017 |
|
EU/1/12/797 |
Eylea |
Iceland |
10.8.2017 |
|
EU/1/12/797 |
Eylea |
Liechtenstein |
31.8.2017 |
|
EU/1/12/797 |
Eylea |
Norway |
18.8.2017 |
|
EU/1/12/798 |
Ibandronic acid Accord |
Iceland |
6.10.2017 |
|
EU/1/12/798 |
Ibandronic acid Accord |
Liechtenstein |
31.10.2017 |
|
EU/1/12/798 |
Ibandronic acid Accord |
Norway |
27.9.2017 |
|
EU/1/12/799 |
Memantine Merz |
Iceland |
24.7.2017 |
|
EU/1/12/799 |
Memantine Merz |
Liechtenstein |
31.8.2017 |
|
EU/1/12/799 |
Memantine Merz |
Norway |
9.8.2017 |
|
EU/1/12/800 |
Zoledronic Acid Hospira |
Iceland |
11.9.2017 |
|
EU/1/12/800 |
Zoledronic acid Hospira |
Liechtenstein |
31.8.2017 |
|
EU/1/12/800 |
Zoledronsyre Hospira |
Norway |
4.9.2017 |
|
EU/1/12/801 |
Constella |
Iceland |
14.9.2017 |
|
EU/1/12/801 |
Constella |
Liechtenstein |
31.10.2017 |
|
EU/1/12/801 |
Constella |
Norway |
22.9.2017 |
|
EU/1/12/802 |
Capecitabine medac |
Iceland |
12.7.2017 |
|
EU/1/12/803 |
NexoBrid |
Iceland |
30.11.2017 |
|
EU/1/12/803 |
NexoBrid |
Liechtenstein |
31.12.2017 |
|
EU/1/12/803 |
NexoBrid |
Norway |
11.12.2017 |
|
EU/1/12/805 |
AMYViD |
Iceland |
9.10.2017 |
|
EU/1/12/805 |
Amyvid |
Liechtenstein |
31.10.2017 |
|
EU/1/12/805 |
Amyvid |
Norway |
3.10.2017 |
|
EU/1/12/806 |
Ryzodeg |
Iceland |
4.10.2017 |
|
EU/1/12/806 |
Ryzodeg |
Liechtenstein |
31.10.2017 |
|
EU/1/12/806 |
Ryzodeg |
Norway |
10.10.2017 |
|
EU/1/12/807 |
Tresiba |
Iceland |
9.10.2017 |
|
EU/1/12/807 |
Tresiba |
Liechtenstein |
31.10.2017 |
|
EU/1/12/807 |
Tresiba |
Norway |
10.10.2017 |
|
EU/1/12/808 |
Imatinib Teva |
Iceland |
9.10.2017 |
|
EU/1/12/808 |
Imatinib Teva |
Liechtenstein |
31.10.2017 |
|
EU/1/12/808 |
Imatinib Teva |
Norway |
27.9.2017 |
|
EU/1/12/809 |
Betmiga |
Iceland |
6.10.2017 |
|
EU/1/12/809 |
Betmiga |
Liechtenstein |
31.10.2017 |
|
EU/1/12/809 |
Betmiga |
Norway |
3.10.2017 |
|
EU/1/12/811 |
Lyxumia |
Iceland |
6.10.2017 |
|
EU/1/12/811 |
Lyxumia |
Liechtenstein |
31.10.2017 |
|
EU/1/12/811 |
Lyxumia |
Norway |
9.10.2017 |
|
EU/1/12/812 |
Bexsero |
Iceland |
9.10.2017 |
|
EU/1/12/812 |
Bexsero |
Liechtenstein |
31.10.2017 |
|
EU/1/12/812 |
Bexsero |
Norway |
3.10.2017 |
|
EU/1/12/814 |
Zaltrap |
Iceland |
9.10.2017 |
|
EU/1/12/814 |
ZALTRAP |
Liechtenstein |
31.10.2017 |
|
EU/1/12/814 |
ZALTRAP |
Norway |
27.9.2017 |
|
EU/1/12/815 |
Selincro |
Iceland |
30.11.2017 |
|
EU/1/12/815 |
Selincro |
Liechtenstein |
31.12.2017 |
|
EU/1/12/815 |
Selincro |
Norway |
1.12.2017 |
|
EU/1/13/813 |
Perjeta |
Iceland |
19.12.2017 |
|
EU/1/13/813 |
Perjeta |
Liechtenstein |
31.12.2017 |
|
EU/1/13/817 |
Actelsar HCT |
Liechtenstein |
31.12.2017 |
|
EU/1/13/819 |
JETREA |
Iceland |
15.12.2017 |
|
EU/1/13/819 |
JETREA |
Liechtenstein |
31.12.2017 |
|
EU/1/13/819 |
JETREA |
Norway |
19.12.2017 |
|
EU/1/13/902 |
Translarna |
Iceland |
12.7.2017 |
|
EU/1/13/902 |
Translarna |
Norway |
5.7.2017 |
|
EU/1/14/987 |
Holoclar |
Iceland |
19.12.2017 |
|
EU/1/16/1094 |
Ninlaro |
Iceland |
6.10.2017 |
|
EU/1/16/1094 |
Ninlaro |
Liechtenstein |
31.10.2017 |
|
EU/1/16/1094 |
Ninlaro |
Norway |
26.9.2017 |
|
EU/1/16/1121 |
Zalmoxis |
Iceland |
24.7.2017 |
|
EU/1/16/1121 |
Zalmoxis |
Liechtenstein |
31.8.2017 |
|
EU/1/16/1121 |
Zalmoxis |
Norway |
4.8.2017 |
|
EU/1/16/1138 |
Venclyxto |
Iceland |
6.11.2017 |
|
EU/1/16/1138 |
Venclyxto |
Norway |
14.11.2017 |
|
EU/1/16/1139 |
Ocaliva |
Iceland |
8.12.2017 |
|
EU/1/16/1139 |
OCALIVA |
Liechtenstein |
31.12.2017 |
|
EU/1/16/1139 |
OCALIVA |
Norway |
18.12.2017 |
|
EU/1/16/1143 |
Lartruvo |
Iceland |
6.10.2017 |
|
EU/1/16/1143 |
Lartruvo |
Liechtenstein |
31.10.2017 |
|
EU/1/16/1143 |
Lartruvo |
Norway |
27.9.2017 |
|
EU/1/16/1169 |
Alecensa |
Iceland |
8.12.2017 |
|
EU/1/16/1169 |
Alecensa |
Liechtenstein |
31.12.2017 |
|
EU/1/16/1169 |
Alecensa |
Norway |
15.12.2017 |
|
EU/1/43/890 |
Cometriq |
Norway |
3.8.2017 |
|
EU/2/12/142 |
Cardalis |
Iceland |
4.7.2017 |
|
EU/2/12/144 |
Contacera |
Iceland |
5.12.2017 |
|
EU/2/12/144 |
Contacera |
Liechtenstein |
31.12.2017 |
|
EU/2/12/144 |
Contacera |
Norway |
15.12.2017 |
|
EU/2/12/145 |
Kexxtone |
Liechtenstein |
31.12.2017 |
|
EU/2/12/145 |
Kexxtone |
Norway |
28.12.2017 |
|
EU/2/12/147 |
Pexion |
Iceland |
5.12.2017 |
|
EU/2/12/147 |
Pexion |
Liechtenstein |
31.12.2017 |
|
EU/2/12/147 |
Pexion |
Norway |
6.12.2017 |
ANNEX III
List of extended marketing authorisations
The following marketing authorisations have been extended in the EEA EFTA States during the period 1 July-31 December 2017:
|
EU Number |
Product |
Country |
Date of authorisation |
|
EU/1/01/177/002 |
SonoVue |
Norway |
4.9.2017 |
|
EU/1/03/256/022 |
Humira |
Iceland |
19.12.2017 |
|
EU/1/03/256/022 |
Humira |
Norway |
10.11.2017 |
|
EU/1/04/292/013-015 |
Mimpara |
Iceland |
15.9.2017 |
|
EU/1/04/292/013-015 |
Mimpara |
Norway |
28.8.2017 |
|
EU/1/06/356/020-022 |
Exjade |
Norway |
28.11.2017 |
|
EU/1/06/356/020-022 |
Exjade |
Iceland |
1.12.2017 |
|
EU/1/07/418/011-013 |
Celsentri |
Norway |
3.8.2017 |
|
EU/1/07/418/011-013 |
Celsentri |
Iceland |
13.7.2017 |
|
EU/1/07/422/015 |
Tasigna |
Iceland |
4.12.2017 |
|
EU/1/07/422/015 |
Tasigna |
Norway |
28.11.2017 |
|
EU/1/07/436/006 |
Isentress |
Iceland |
9.8.2017 |
|
EU/1/07/436/006 |
Isentress |
Norway |
7.8.2017 |
|
EU/1/08/481/004-005 |
Kuvan |
Iceland |
10.8.2017 |
|
EU/1/08/481/004-005 |
Kuvan |
Norway |
13.7.2017 |
|
EU/1/09/522/003 |
ellaOne |
Iceland |
1.12.2017 |
|
EU/1/09/522/003 |
ellaOne |
Norway |
10.11.2017 |
|
EU/1/09/531/022-033 |
Instanyl |
Iceland |
6.11.2017 |
|
EU/1/09/539/005-006 |
Samsca |
Iceland |
5.10.2017 |
|
EU/1/09/539/005-006 |
Samsca |
Norway |
18.9.2017 |
|
EU/1/10/618 |
Prolia |
Norway |
27.9.2017 |
|
EU/1/11/703 |
Xgeva |
Norway |
27.9.2017 |
|
EU/1/12/753/018-019 |
Signifor |
Iceland |
4.10.2017 |
|
EU/1/12/753/018-019 |
Signifor |
Norway |
18.9.2017 |
|
EU/1/12/787/003 |
Revestive |
Norway |
5.7.2017 |
|
EU/1/12/787/003 |
Revestive |
Iceland |
13.7.2017 |
|
EU/1/13/846/002-003 |
Xtandi |
Norway |
3.10.2017 |
|
EU/1/13/846/002-003 |
Xtandi |
Iceland |
6.10.2017 |
|
EU/1/13/860/003 |
Nexium Control |
Iceland |
11.7.2017 |
|
EU/1/13/860/003 |
Nexium Control |
Norway |
5.7.2017 |
|
EU/1/15/1070/002 |
Oncaspar |
Iceland |
19.12.2017 |
ANNEX IV
List of withdrawn marketing authorisations
The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July-31 December 2017:
|
EU Number |
Product |
Country |
Date of withdrawal |
|
EU/1/00/167 |
Prevenar |
Liechtenstein |
31.12.2017 |
|
EU/1/00/167 |
Prevenar |
Norway |
11.12.2017 |
|
EU/1/00/167 |
Prevenar |
Iceland |
1.12.2017 |
|
EU/1/07/394 |
Optaflu |
Norway |
18.10.2017 |
|
EU/1/07/398 |
Optimark |
Iceland |
10.10.2017 |
|
EU/1/09/561 |
Clopidogrel Teva Pharma |
Iceland |
11.7.2017 |
|
EU/1/11/674 |
Repso |
Liechtenstein |
31.8.2017 |
|
EU/1/11/674 |
Repso |
Norway |
8.8.2017 |
|
EU/1/11/674 |
Repso |
Iceland |
10.8.2017 |
|
EU/1/13/868 |
EVARREST |
Liechtenstein |
31.12.2017 |
|
EU/1/13/868 |
EVARREST |
Norway |
28.11.2017 |
|
EU/1/13/868 |
EVARREST |
Iceland |
4.12.2017 |
|
EU/1/14/976 |
Zontivity |
Liechtenstein |
31.8.2017 |
|
EU/1/15/996 |
Ristempa |
Liechtenstein |
31.10.2017 |
|
EU/1/15/996 |
Ristempa |
Norway |
9.10.2017 |
|
EU/1/15/996 |
Ristempa |
Iceland |
9.10.2017 |
|
EU/1/16/1113 |
Enzepi |
Iceland |
11.8.2017 |
|
EU/1/16/1113 |
Enzepi |
Liechtenstein |
31.8.2017 |
|
EU/1/16/1113 |
Enzepi |
Norway |
8.8.2017 |
ANNEX V
List of suspended marketing authorisations
The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 July-31 December 2017:
|
EU Number |
Product |
Country |
Date of suspension |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|